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Completed

NCT Number: NCT02731976

Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.

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Key information

Conditions

Human Microbiome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy participants aged >=16

Exclusion criteria

  • Known gastrointestinal disorder
  • Known food intolerance

Treatment and study plan

Dietary Intervention

Other

Primary outcomes

  1. Changes in gut microbiota composition upon gluten-free diet intervention

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Secondary outcomes

  1. Changes in gut associated biomarker levels: fecal calprotectin

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  2. Changes in gut associated biomarker levels: plasma cytokines: IL-1beta

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  3. Changes in gut associated biomarker levels: fecal human beta defensin 2

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  4. Changes in gut associated biomarker levels: fecal chromogranin A

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  5. Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  6. Changes in gut associated biomarker levels: plasma citrulline

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  7. Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  8. Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  9. Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  10. Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  11. Changes in gut associated biomarker levels: plasma cytokines: IL-6

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  12. Changes in gut associated biomarker levels: plasma cytokines: IL-8

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  13. Changes in gut associated biomarker levels: plasma cytokines: IL-10

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  14. Changes in gut associated biomarker levels: plasma cytokines: IL-12

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

  15. Changes in gut associated biomarker levels: plasma cytokines: TNFalpha

    Time frame: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Apr 8, 2016
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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